CMS-1000FM CENTRAL MONITORING SYSTEM


Device Classification Name

system, monitoring, perinatal

510(k) Number K112159
Device Name CMS-1000FM CENTRAL MONITORING SYSTEM
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 west 20 st
hialeah, 
FL 
33010

Applicant Contact jorge millan
Correspondent
ADVANCED INSTRUMENTATIONS, INC.
601 west 20 st
hialeah, 
FL 
33010

Correspodent Contact jorge millan
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 07/27/2011
Decision Date 09/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No